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CARsgen Announces Data of Allogeneic BCMA CAR-T Cell Therapy CT0596 for Relapsed/Refractory Multiple Myeloma at the 2025 ASH Annual Meeting

Six of eight patients with relapsed/refractory multiple myeloma achieved partial response or better with CT0596, showing favorable safety and efficacy in a Phase 1 trial.

  • Presenting at ASH, CARsgen reported preliminary favorable tolerability and encouraging efficacy for CT0596 earlier this year, according to the poster shown at the 67th American Society of Hematology Annual Meeting.
  • The dose‑escalation trial NCT06718270 enrolled 8 patients, all evaluable as of Aug. 31, 2025, with CT0596 dosed at 1.5×10x and varied lymphodepletion regimens.
  • Response and MRD data reveal six patients achieving PR or better, including 3 CR/sCR, and six full-dose patients achieved MRD-negativity at Week 4.
  • CT0596 showed a manageable safety profile, with no ICANS or GVHD reported and no dose‑limiting toxicities or deaths; CARsgen plans an Investigational New Drug submission in the second half of 2025 and a Phase 1b registrational study in 2026.
  • CARsgen's capabilities position the company to advance CT0596 through investigator‑initiated trials for relapsed/refractory multiple myeloma and plasma cell leukemia, targeting plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells with its THANK‑u Plus platform.
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CARsgen Announces Data of Allogeneic BCMA CAR-T Cell Therapy CT0596 for Relapsed/Refractory Multiple Myeloma at the 2025 ASH Annual Meeting

SHANGHAI, Dec. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that clinical data from its allogeneic BCMA-targeted CAR T-cell product candidate, CT0596, for the treatment of relapsed/refractory…

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Charleston Gazette-Mail broke the news in Charleston, United States on Monday, December 8, 2025.
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